Operating room personnel have been aware for years that the repeated touching of the operating room or surgical lamp handle to redirect the illumination pattern or to bring the lamp closer to the area of concern, or to move the lamp farther away, can bring about the spread of contagious diseases through contact with the handle. Such contagious or communicable diseases are borne in or on the human body fluids and tissues which become attached to the exterior surfaces of the gloved (or ungloved) hands of operating personnel, doctors, nurses and other technicians, and are transmitted to the lamp handle or adjusting means through direct contact.
In the environment in which operating room personnel work, i.e. inside the human body, body fluids such as blood and the tissues comprising the organs, muscles and skin of the human body may potentially transmit a number of diseases and viral infections through contact. The process of surgery requires the incision or cutting into the body resulting in the outflow of blood and other body fluids as well as the scattering of various body tissues outside of the point of incision or cut. Some of such fluids and particles of tissues may become attached to the gloved hands of the operating room personnel. Cleaning and sterilization of the lamp handles or adjusting means has remained a serious problem for operating room and other hospital personnel because of their construction and the materials utilized to formulate the handle.
During operating procedures the lamp is almost continually repositioned for better lighting into the point of incision, the interior of the patient's body. The lamp handle is touched by a variety of operating room personnel in attempts to refocus the light onto the desired point of illumination on or in the body of the patient. Refocusing the light emitted by the lamp is accomplished with possibly contaminated exterior surfaces of the gloves worn by the operating room personnel who are still performing the surgical procedure. Anything such personnel may have come into contact with (known or unknown) while their gloved hands were in contact with the human patient will necessarily be transmitted to the surface of the lamp handle or other adjusting means upon touching the surface of such handle or adjusting means.
There have been some attempts to provide covers for surgical lamps for use in a surgical operatory. The phrase “semi-rigid” in the prior art describes a very specific category of surgical light handle covers, as opposed to “flexible” and “rigid”.
Semi-rigid surgical light handle covers are described in U.S. Pat. Nos. 4,559,671 and 4,605,124. These patents disclose semi-rigid covers for principally protecting the grip portion of the handle of the surgical lamp, as well as an upward and radially outward extending projection which serves to prevent contact with the handle support elements of the surgical lamp. Other semi-rigid surgical lamp handle covers are disclosed in U.S. Pat. No. 4,844,252 and U.S. D298,864.
Rigid light handle covers are well known in the art as having essentially no ability to be deformed by normal human hand strength, which preclude their storage or manipulation in a space smaller than their undeformed shape. In contrast, “flexible” light handle covers are entirely flexible and are collapsible so as to be folded into a small container, bag or pouch. In contrast, semi-rigid light handle covers of the prior art cannot, without relatively substantial pressure and an appropriately expensive container, be compressed into a small container, bag or pouch, although the structural advantage of the semi-rigid light handle cover over the flexible light handle cover is very substantial, in that application of the semi-rigid light handle cover to the rigid light handle connected to the surgical lamp or light is with low risk of being unable to move the entire piece into fixed connection with the rigid light handle as compared with the “floppy” and non-resistant structure of the flexible light handle cover. The “floppy” nature of the flexible light handle cover provides storage advantage as compared with the semi-rigid light handle cover, but the flexible light handle cover is inherently more risky to use in the surgical suite as opposed to the semi-rigid light handle cover.
However, the current state of the art has shown a substantial disadvantage of the semi-rigid light handle cover, in that its more rigid structure than the flexible light handle cover typically requires more connection force directed toward a longitudinal axis of the rigid light handle in order to obtain the necessary fixation connection. Because surgical lights or lamps must by their very nature be easily movable and positionable with slight force from surgical personnel, said connection force causes displacement of the entire arm of the surgical lamp or light away from the user and resulting in necessarily contaminating an opposite gloved hand of that user to grab the arm of the surgical lamp to force the semi-rigid light handle cover onto fixed connection with the rigid light handle.
There is a need for a light handle cover that combines the advantages of the flexible light handle cover and the semi-rigid light handle cover, which is a present object of the invention.
It is, therefore, an object of the present invention to provide a clean or sterile field around an operating room (surgical) or treatment (clinical) lamp handle or adjusting means in order to alleviate, or entirely eliminate, the task of removal and sterilization of the handles or adjusting means.
It is still a further object of the present invention to provide a barrier or shield which is disposable after a single use and which is easily applied and removed so that the barrier or shield will have greater acceptance among users in the healthcare field.